Nutrition impact symptom monitoring and weight loss outcomes: a longitudinal radiotherapy study.

OBJECTIVES: Nutrition impact symptoms (NIS) are associated with weight loss (WL), and decreased energy intake in cross-sectional studies. We aimed to ascertain associations between changes in NIS burden, energy intake and WL over time in patients with advanced cancer. METHODS: Adult patients from an observational radiotherapy study for painful bone metastases self-reported NIS and WL using the Patient-Generated Subjective Global Assessment tool (PG-SGA) at baseline and week eight (W8). NIS burden, the sum of NIS per patient, categorised as 0, 1-2 and ≥3 with changes defined as 2-point differences from baseline to W8 were used. Energy intake was assessed by 24-hour recall interviews. RESULTS: 111 patients (72.1%) were analysed and grouped by NIS burden; 0 NIS (44.1%), 1-2 NIS (30.6%) and ≥3 NIS (25.2%). Patients with NIS burden of ≥3 reported higher baseline WL compared with those with 1-2 or 0 NIS (46.4% vs 18.2% vs 10.2%, respectively, p=0.002). At W8, 21 patients (19%) reported improved NIS burden, accompanied by a lower proportion of severe (≥5%) new-onset WL (19% vs 42.1%) and higher energy intake (median 29.6 vs 21.2 kcal/kg) than those with worsened NIS burden (17.1%). CONCLUSIONS: NIS management may improve energy intake and prevent WL, emphasising the importance of systematic follow-up and interventions. CLINICALTRIALSGOV REGISTRATION: NCT02107664.

Benefits of Study Participation for Patients with Advanced Cancer Receiving Radiotherapy: A Prospective Observational Study.

Background: Patients with advanced cancer and bone metastases may have unmet palliative care (PC) needs that go unnoticed during clinical oncological practice. This observational study describes interventions that were initiated as the patients participated in the Palliative Radiotherapy and Inflammation Study (PRAIS). It was hypothesized that the patients would benefit from study participation due to PC interventions initiated by the study team. Methods: A retrospective review of patients' electronic records. Patients with advanced cancer and painful bone metastases included in PRAIS were eligible. All patients met with the study team before start of radiotherapy, after completion of Patient Reported Outcome Measures. Interventions initiated by the study team were documented in the patients' electronic records. Results: A total of 133 patients were reviewed: 63% males, mean (standard deviation [SD]) age 65 (9.6) and mean (SD) Karnofsky performance status (KPS) score 73.2 (9.1). Interventions were initiated in 50% (n = 67) of the patients. Changes in opioid management (69%), treatment of constipation (43%), and nausea (24%) and nutritional advice were most frequent (21%). Patients receiving interventions had lower mean KPS (70 vs. 77 p < 0.001), shorter survival time after study inclusion (median 28 vs. 57.5 weeks p = 0.005) and were more often opioid naïve (12% vs. 39% p < 0.001) than those not receiving interventions by the study team. Conclusions: Patients with advanced cancer and painful bone metastasis benefited from study participation due to multiple PC interventions initiated by the study team. The findings call for a systematic integration of PC in patients with advanced cancer. Trial Registration: ClinicalTrials.gov NCT02107664.

Clinical Predictors for Analgesic Response to Radiotherapy in Patients with Painful Bone Metastases.

BACKGROUND: Radiotherapy (RT) reduces pain in about 60% of patients with painful bone metastases, leaving many patients without clinical benefit. This study assesses predictors for RT effectiveness in patients with painful bone metastases. MATERIALS AND METHODS: We included adult patients receiving RT for painful bone metastases in a multicenter, multinational longitudinal observational study. Pain response within 8 weeks was defined as ≥2-point decrease on a 0-10 pain score scale, without increase in analgesics; or a decrease in analgesics of ≥25% without increase in pain score. Potential predictors were related to patient demographics, RT administration, pain characteristics, tumor characteristics, depression and inflammation (C-reactive protein [CRP]). Multivariate logistic regression analysis with multiple imputation of missing data were applied to identify predictors of RT response. RESULTS: Of 513 eligible patients, 460 patients (90 %) were included in the regression model. 224 patients (44%, 95% confidence interval (CI) 39%-48%) responded to RT. Better Karnofsky performance status (Odds ratio (OR) 1.39, CI 1.15-1.68), breast cancer (OR 2.54, CI 1.12-5.73), prostate cancer (OR 2.83, CI 1.27-6.33) and soft tissue expansion (OR 2.00, CI 1.23-3.25) predicted RT response. Corticosteroids were a negative predictor (OR 0.57, CI 0.37-0.88). Single and multiple fraction RT had similar response. The discriminative ability of the model was moderate; C-statistic 0.69. CONCLUSION: This study supports previous findings that better performance status and type of cancer diagnosis predicts analgesic RT response, and new data showing that soft tissue expansion predicts RT response and that corticosteroids is a negative predictor for RT response in patients with painful bone metastases.

Symptom cluster of pain, fatigue, and psychological distress in breast cancer survivors: prevalence and characteristics.

PURPOSE: Breast cancer survivors may experience pain, fatigue, or psychological distress as a result of the treatment. These symptoms may co-occur and form a cluster. However little is known about symptom clusters (SCs) in long-term breast cancer survivors. This study aimed to identify subgroups of breast cancer survivors with the SC of pain, fatigue, and psychological distress, and to examine sociodemographic and clinical characteristics associated with this SC. METHODS: Data were obtained from a nationwide survey of breast cancer survivors (N = 834). Exhaustive enumeration of possible combination of the three binary variables (pain, fatigue, psychological distress) was conducted. They were identified using the recommended threshold for the Hospital Anxiety and Depression Scale, the Fatigue Questionnaire, and a score of one or more on a numeric rating scale for pain. The SC was defined to include all the three variables, all other combinations were defined as no SC. Logistic regression analyses were conducted to examine the association between sociodemographic and clinical variables and the SC. RESULTS: Of the 834 survivors, 13% had the SC. Younger age (OR 2.3, 95% CI 1.3-4.1, p = 0.003), lymphedema (OR 1.9, 95% CI 1.1-3.2, p = 0.02), working part-time (OR 2.9, 95% CI 1.6-5.3, p < 0.001), or being disabled (OR 4.1, 95% CI 2.2-7.8, p < 0.001) were all associated with the SC. CONCLUSION: Thirteen percent of the survivors experienced the SC. It appears that premenstrual women are at greater risk, than postmenopausal women. Having this SC might have an impact on the survivors' ability to work.

The Palliative Radiotherapy and Inflammation Study (PRAIS) - protocol for a longitudinal observational multicenter study on patients with cancer induced bone pain.

BACKGROUND: Radiation therapy (RT) results in pain relief for about 6 of 10 patients with cancer induced bone pain (CIBP) caused by bone metastases. The high number of non-responders, the long median time from RT to pain response and the risk of adverse effects, makes it important to determine predictors of treatment response. Clinical features such as cancer type, performance status and pain intensity, and biomarkers for osteoclast activity are proposed as predictors of response to RT. However, results are inconsistent and there is a need for better predictors of RT response. A similar argument can be stated for the development of cachexia; there are currently no predictors that can identify patients who will develop cachexia later in the cancer disease trajectory. Experimental and preclinical studies show that pain, depression and cachexia are related to inflammation. However, it is not known if inflammatory biomarkers can predict CIBP, depression or development of cachexia. METHODS: This multicenter, multinational longitudinal observational study will include 600 adult patients receiving RT for CIBP. Demographic data, clinical variables, osteoclast and inflammatory biomarkers will be assessed before start of RT, and 3, 8, 16, 24 and 52 weeks after last course of RT. The primary aim of the study is to identify potential predictors for pain relief from RT. Secondary aims are to explore potential predictors for development of cachexia, the longitudinal relationship between pain intensity and depression, and if inflammatory biomarkers are associated with changes in pain intensity, cachexia and depression during one-year follow up. DISCUSSION: The immediate clinical implication of the PRAIS study is to identify potential predictive factors for a RT response on CIBP, and thereby reduce non-efficacious RT. Patient benefits are fewer hospital visits, reduced risk of adverse effects and more individualized pain treatment. The long-term clinical implication of the PRAIS study is to improve the knowledge about inflammation in relation to CIBP, cachexia and depression and potentially identify associations and mechanisms that can be targeted for treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT02107664 , date of registration April 8, 2014 (retrospectively registered). TRIAL SPONSOR: The European Palliative Care Research Centre (PRC), Department of Clinical and Molecular Medicine, NTNU, Faculty of medicine and Health Sciences, Trondheim, N-7491, Norway.